GUEST COLUMNISTS

• Gaining An Edge In GLP-1 Production

  The shortage-driven production of GLP-1 drugs of the past few years is giving way to a long-term operation model characterized by digital enablement and supply chain resilience.

• How Generic Pharma Manufacturers Can Rebuild Margins Inside The Four Walls

  The pricing dynamics for generic drugs turns formerly attractive products into high-volume, low-margin commodities. Lean and Six Sigma in four key areas can unlock efficiencies.

• Causal Mechanism And Effect Analysis (CMEA): FMEA's Simpler, Effective Alternative

  This article describes causal mechanism and effect analysis (CMEA) as an alternative to failure mode and effect analysis (FMEA) for analyzing and managing the industry’s risks.

• The Stepwise Path Lilly Mapped From Paper To Digital Logbooks

  Eli Lilly and Company started at the front lines, on the shop floor gathering operator input, when switching from paper to digital logbooks.

• Minimizing Regulatory Risk For Biologics Manufacturing Changes

  Any manufacturing process change for a biologic can raise comparability questions. Here’s a practical, action-oriented strategy to ensure health authorities are satisfied.

• Building Quality Into Radiopharmaceuticals: A Look At EMA's Recent Guideline

  The EMA's December 2025 draft guideline on expectations for the quality documentation of radiopharmaceuticals replaces the earlier 2007 guideline and reflects significant developments.

• Overcoming 3 Key Challenges Of Working With CDMOs For Radiopharmaceuticals

  Radiopharmaceuticals have a level of operational complexity that challenges traditional outsourcing models. Address these three critical challenges early and intentionally.

• Selecting The Right eQMS To Maximize Quality Maturity

  Let's take a closer look at the current electronic quality management system (eQMS) landscape in pharma/biotech and what a future-ready eQMS must enable to support continuous improvement.